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NCT Number: NCT05940935

The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations

The relationship of developing metabolic acidosis with antiepleptic drugs in craniotomy operations

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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Anesthesia Management Antiepileptic Drugs Craniotomy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

About this study

Metabolic acidosis is a life-threatening complication in the perioperative, intraoperative and postoperative period. It can cause decreased cardiac output, electrolyte imbalance, surgical bleeding and neurological complications, even coma and death in surgical patients.

Topiramate and zonisamide are sulfonamide derivative compounds used in the treatment of epilepsy. It has been shown in studies that both drugs have a strong inhibition of carbonic anhydrase enzyme. Recent case reports suggest that both drugs may cause metabolic acidosis by lowering serum bicarbonate levels in some patients.

Aim in this study is to determine the relationship between preoperative, intraoperative and postoperative metabolic acidosis and to emphasize the importance of anesthesia management in patients who have undergone craniotomy and use antiepileptic drugs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs
  • ASA I-III
  • Patients undergoing elective surgery

Exclusion criteria

  • Patients with a surgical procedure time of more than 5 hours
  • Patients who received more than 2 units of blood transfusion during the operation
  • Patients taking other drugs that can cause metabolic acidosis
  • Patients with diabetes mellitus, diabetes insipidus, hepatic or renal disease

Treatment and study plan

Arterial Blood Gas Base Deficit

Procedure

The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

Primary outcomes

  1. Preoperative Metabolic Acidosis

    Time frame: Baseline

    The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

  2. Intraoperative Metabolic Acidosis

    Time frame: during the operation

    The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

  3. Postoperative Metabolic Acidosis

    Time frame: Day 1

    The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations; Does Topiramat or Zonisamide Cause Metabolic Acidosis?

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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